A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy
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ClinicalTrials.gov Identifier: NCT00006190 |
Recruitment Status
:
Completed
First Posted
: August 28, 2000
Last Update Posted
: March 2, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Lipodystrophy | Drug: Nelfinavir mesylate Drug: Stavudine Drug: Lamivudine Drug: Efavirenz | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Masking: | Double |
Primary Purpose: | Diagnostic |
Official Title: | The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients |
Study Start Date : | November 2000 |
Study Completion Date : | November 2001 |


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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- CD4 count > 200 cells/mm
- HIV RNA (viral load) <= 100,000 copies/ml
- No previous antiviral therapy
Exclusion Criteria:
- AIDS or opportunistic infections
- Active intravenous drug users
- Use of: corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, oxandrolone, megace, dehydroepiandrosterone.
- Subjects with diabetes mellitus
- Subjects who consume > 2 alcoholic drinks per day
- Pregnant women, premenopausal women unless adequate birth control is in use.
- Acute or chronic liver diseases, liver enzymes elevations > 2.5 times the upper limit of normal.
- Anemia, an Hct < 35% for men, or < 32% for women.
- Abnormal thyroid function tests.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006190
United States, Texas | |
UT Southwestern Medical Center | |
Dallas, Texas, United States, 75390-9103 |
Principal Investigator: | Dr. Abhimanyu Garg | UT Southwestern Medical Center | |
OverallOfficial: | Dr. Dolores Peterson | UT Southwestern Medical Center | |
OverallOfficial: | Dr. Ruth Berggren | UT Southwestern Medical Center |
Publications:
ClinicalTrials.gov Identifier: | NCT00006190 History of Changes |
Other Study ID Numbers: |
lipod (completed) R01DK056583-01 ( U.S. NIH Grant/Contract ) |
First Posted: | August 28, 2000 Key Record Dates |
Last Update Posted: | March 2, 2010 |
Last Verified: | March 2010 |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Lipoproteins Insulin resistance Adipose tissue |
Additional relevant MeSH terms:
HIV Infections Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Lamivudine |
Efavirenz Stavudine Nelfinavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers |